New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

08/27/2009

Trade Name:

Zenpep

Generic Name or Proper Name (*):

pancrelipase

Indications Studied:

Exocrine pancreatic insufficiency due to cystic fibrosis

Label Changes Summary:

* Safety and efficacy assessed in 2 studies which included pediatric patients ages 1-17 years * Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase with the same active ingredient. * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures in children <12 years of age * AEs similar to adults * Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce * Information on dosing, and clinical studies * Not interchangeable with other pancrelipase products * New drug